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1.
Coron Artery Dis ; 11(6): 467-72, 2000 Sep.
Article in English | MEDLINE | ID: mdl-10966132

ABSTRACT

BACKGROUND: The development of mature coronary collateral vessels in patients with obstructive coronary artery disease (CAD) decreases the ischemic myocardial burden. Chronic bradycardia has been shown to stimulate formation of collateral vessels in experimental models. OBJECTIVE: To test our hypothesis that CAD patients with bradycardia would have better developed collateral circulation than would members of a control group. DESIGN: A retrospective study examining the relationship between bradycardia and the development of coronary collateral vessels in patients with obstructive CAD. METHODS: Admission electrocardiograms and rhythm tracings obtained during angiography of all patients presenting to the cardiac catheterization laboratory were screened from January to October 1997. Angiograms for patients with heart rates < or = 50 beats/min were reviewed. An equivalent number of consecutive patients with heart rates > or = 60 beats/min served as controls. Patients with acute myocardial infarction, with rhythms other than sinus, and without high grade obstructive CAD (< 70% stenosis) were excluded from the study. RESULTS: The study population consisted of 61 patients, 30 having heart rates < or = 50 beats/min (group A), and 31 controls with heart rates > or = 60 beats/min (group B). A significantly greater proportion of patients in group A than of matched controls was demonstrated to have developed collaterals (97 versus 55% in group B, P < 0.005). The mean collateral grades were 1.66 and 0.95 for subjects in groups A and B, respectively (P < 0.001). CAD patients with bradycardia are more likely (odds ratio 24, 95% confidence interval 5-146) to have angiographic coronary collaterals than are those with higher heart rates. CONCLUSION: Results of this study demonstrate that there is an association between bradycardia and growth of collateral vessels in patients with obstructive CAD. Bradycardic agents may be useful for promoting development of coronary collaterals in patients with atherosclerotic disease.


Subject(s)
Bradycardia/physiopathology , Collateral Circulation , Coronary Disease/physiopathology , Neovascularization, Physiologic , Aged , Case-Control Studies , Coronary Angiography , Coronary Circulation/physiology , Coronary Disease/classification , Coronary Disease/diagnostic imaging , Electrocardiography , Female , Humans , Male , Middle Aged , Retrospective Studies , Severity of Illness Index
2.
Circulation ; 102(5): 523-30, 2000 Aug 01.
Article in English | MEDLINE | ID: mdl-10920064

ABSTRACT

BACKGROUND: Intravascular ultrasound (IVUS) can assess stent geometry more accurately than angiography. Several studies have demonstrated that the degree of stent expansion as measured by IVUS directly correlated to clinical outcome. However, it is unclear if routine ultrasound guidance of stent implantation improves clinical outcome as compared with angiographic guidance alone. METHODS AND RESULTS: The CRUISE (Can Routine Ultrasound Influence Stent Expansion) study, a multicenter study IVUS substudy of the Stent Anti-thrombotic Regimen Study, was designed to assess the impact of IVUS on stent deployment in the high-pressure era. Nine centers were prospectively assigned to stent deployment with the use of ultrasound guidance and 7 centers to angiographic guidance alone with documentary (blinded) IVUS at the conclusion of the procedure. A total of 525 patients were enrolled with completed quantitative coronary angiography, quantitative coronary ultrasound, and clinical events adjudicated at 9 months for 499 patients. The IVUS-guided group had a larger minimal lumen diameter (2.9+/-0.4 versus 2.7+/-0. 5 mm, P<0.001) by quantitative coronary angiography and a larger minimal stent area (7.78+/-1.72 versus 7.06+/-2.13 mm(2), P<0.001) by quantitative coronary ultrasound. Target vessel revascularization, defined as clinically driven repeat interventional or surgical therapy of the index vessel at 9 month-follow-up, occurred significantly less frequently in the IVUS-guided group (8.5% versus 15.3%, P<0.05; relative reduction of 44%). CONCLUSIONS: These data suggest that ultrasound guidance of stent implantation may result in more effective stent expansion compared with angiographic guidance alone.


Subject(s)
Coronary Disease/diagnostic imaging , Coronary Disease/therapy , Coronary Vessels/diagnostic imaging , Stents , Ultrasonography, Interventional , Aspirin , Coronary Angiography , Coronary Disease/mortality , Coumarins/therapeutic use , Female , Fibrinolytic Agents/therapeutic use , Humans , Male , Middle Aged , Myocardial Infarction/epidemiology , Ticlopidine/therapeutic use , Treatment Outcome
4.
J Am Coll Cardiol ; 34(3): 698-706, 1999 Sep.
Article in English | MEDLINE | ID: mdl-10483950

ABSTRACT

OBJECTIVES: This registry collected the 30-day and 9-month clinical outcomes of patients whose coronary stent implantation was suboptimal, and compared them with the cohort of patients with "optimal" stenting in the randomized portion of the STent Anti-thrombotic Regimen Study (STARS) trial. BACKGROUND: Although "optimal" stenting combined with an aspirin and ticlopidine regimen carries a low (0.5%) incidence of subacute stent thrombosis, only limited data are available for patients in whom stents are deployed suboptimally. METHODS: In the STARS, 312 (15.9%) of 1,965 patients enrolled were excluded from participation in the randomized trial based on a perceived "suboptimal" result of coronary stenting. Of these, 265 patients met prespecified criteria for suboptimal stenting, and were followed in a parallel registry, which was compared with the randomized STARS optimal stenting cohort. The primary end point was a 30-day composite of death, emergent target lesion revascularization, angiographic thrombosis of the target vessel without revascularization and nonfatal myocardial infarction (MI) unrelated to direct procedural complications. RESULTS: Registry patients had a similar frequency of the primary end point compared with the overall randomized cohort (3.0% vs. 2.2%), with this end point correlating to use of multiple stents, smaller final lumen diameter and absence of ticlopidine from the poststent regimen. Overall 30-day mortality (1.1% vs. 0.06%, p = 0.009) and periprocedural non-Q wave MI (8.7% vs. 4.2%, p = 0.003) were more frequent in registry patients, and appeared to be related to acute procedural complications. Clinical restenosis was significantly higher for registry patients (26.8% vs. 16.0%, p = 0.001), relating to greater prevalence of independent predictors such as smaller final lumen diameter and multiple stent use. CONCLUSIONS: In the STARS registry, the inability to perform optimal stenting correlated with smaller final lumen diameter and longer stent length. With ticlopidine-containing regimens, the acute clinical results of "suboptimal" stent deployment are clinically acceptable, although they are not quite as good as those of optimal stenting using similar drug therapy.


Subject(s)
Angioplasty, Balloon, Coronary/statistics & numerical data , Coronary Disease/therapy , Coronary Thrombosis/prevention & control , Outcome and Process Assessment, Health Care/statistics & numerical data , Registries , Stents/statistics & numerical data , Acute Disease , Aged , Female , Humans , Logistic Models , Male , Middle Aged , Recurrence , Registries/statistics & numerical data , Statistics, Nonparametric , Time Factors , United States
5.
Am J Cardiol ; 84(1): 37-40, 1999 Jul 01.
Article in English | MEDLINE | ID: mdl-10404848

ABSTRACT

We sought to determine the patient and plaque characteristics associated with the different forms of arterial remodeling as seen by intravascular ultrasound (IVUS) before coronary intervention. Remodeling in response to plaque accumulation may occur in the form of compensatory enlargement and/or focal vessel contraction. Previous studies report variation in the frequency and form of arterial remodeling. We performed preintervention IVUS imaging on 169 patients. Vessels were categorized as exhibiting compensatory enlargement or focal contraction if the arterial area at the lesion was larger or smaller, respectively, than both proximal and distal reference arterial areas; otherwise the artery was considered not to have undergone significant remodeling. Calcification was assessed and noncalcified plaque density was measured by videodensitometry. Sixty-one of 169 patients (66 narrowings) (46 men and 15 women, age 56+/-11 years) had adequate reference segments. Remodeling occurred in 43 of 66 patients (65%): compensatory enlargement in 27 of 66 (41%) and focal contraction in 16 of 66 (24%). Lesions with focal contraction had significantly smaller arterial area (13.3+/-3.3 vs. 18.1+/-7.0 mm2, p = 0.02) and plaque area (9.5+/-2.8 vs 13.7+/-5.5 mm2, p<0.01). Cross-sectional stenosis was similar (71+/-9% vs. 75+/-10%, p = NS), as was plaque density (p = 0.20), eccentricity, and calcium. Patient age, gender, and lesion location were not related to the form of remodeling. Similarly, history of diabetes, hypercholesterolemia, or hypertension was not predictive. Smoking was the only risk factor associated with focal contraction (p<0.01). Thus, whereas compensatory enlargement appears to be the most common form of coronary artery remodeling, focal contraction occurs more often in smokers.


Subject(s)
Coronary Artery Disease/diagnostic imaging , Coronary Vessels/diagnostic imaging , Ultrasonography, Interventional , Coronary Artery Disease/epidemiology , Coronary Artery Disease/pathology , Coronary Vessels/pathology , Female , Humans , Male , Middle Aged , Risk Factors , Smoking/epidemiology
6.
N Engl J Med ; 339(23): 1665-71, 1998 Dec 03.
Article in English | MEDLINE | ID: mdl-9834303

ABSTRACT

BACKGROUND: Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of three antithrombotic-drug regimens - aspirin alone, aspirin and warfarin, and aspirin and ticlopidine - after coronary stenting. METHODS: Of 1965 patients who underwent coronary stenting at 50 centers, 1653 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (557 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidine (546 patients). All clinical events reflecting stent thrombosis were included in the prespecified primary end point: death, revascularization of the target lesion, angiographically evident thrombosis, or myocardial infarction within 30 days. RESULTS: The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive aspirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and ticlopidine (P=0.001 for the comparison of all three groups). Hemorrhagic complications occurred in 10 patients (1.8 percent) who received aspirin alone, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all three groups); the incidence of vascular surgical complications was 0.4 percent (2 patients), 2.0 percent (11 patients), and 2.0 percent (11 patients), respectively (P=0.01). There were no significant differences in the incidence of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) among the three treatment groups. CONCLUSIONS: As compared with aspirin alone and a combination of aspirin and warfarin, treatment with aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications than with aspirin alone. After coronary stenting, aspirin and ticlopidine should be considered for the prevention of the serious complication of stent thrombosis.


Subject(s)
Anticoagulants/therapeutic use , Aspirin/therapeutic use , Coronary Disease/therapy , Platelet Aggregation Inhibitors/therapeutic use , Stents , Thrombosis/prevention & control , Ticlopidine/therapeutic use , Warfarin/therapeutic use , Aged , Angioplasty, Balloon, Coronary , Anticoagulants/adverse effects , Aspirin/adverse effects , Coronary Disease/mortality , Drug Therapy, Combination , Female , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/adverse effects , Single-Blind Method , Ticlopidine/adverse effects , Warfarin/adverse effects
8.
Am J Cardiol ; 80(6): 696-9, 1997 Sep 15.
Article in English | MEDLINE | ID: mdl-9315571

ABSTRACT

Although the use of composite end points in clinical trials has increased in recent years, few data are available on the validity of such an approach. In the Thrombolysis In Myocardial Infarction (TIMI) 4 and 5 trials, we set out to validate prospectively the nonfatal components of the "unsatisfactory outcome" end point. This end point consisted of the in-hospital occurrence or observation of new-onset severe congestive heart failure/shock, left ventricular ejection fraction <40% (or <30% for patients with prior myocardial infarction), reinfarction, reocclusion by sestamibi perfusion imaging, TIMI flow grade <2 at 90 minutes or 18 to 36 hours, intracranial hemorrhage, major spontaneous hemorrhage, or anaphylaxis. Among 576 patients in TIMI 4 and 5 with 1-year follow-up, a nonfatal unsatisfactory outcome end point was reached in hospital in 45% of patients. Compared with patients without such an end point, patients with an end point had a relative risk of 1-year mortality of 2.5 (95% confidence interval 1.4 to 5.6, p = 0.001). For individual components, new-onset severe congestive heart failure/shock had a relative risk of 4.6 (p = 0.001), left ventricular ejection fraction <40% had a relative risk of 3.5 (p = 0.006), recurrent myocardial infarction had a relative risk of 2.2 (p = 0.047), and TIMI flow grade <2 at 90 minutes had a relative risk of 2.2 (p = 0.005). Our findings show that these nonfatal in-hospital end points and the composite end point are associated with an increased risk of 1-year mortality and as such are valid predictive survival markers for use in clinical trials.


Subject(s)
Heart Diseases/mortality , Myocardial Infarction/drug therapy , Treatment Outcome , Aged , Clinical Trials as Topic/methods , Fibrinolytic Agents/therapeutic use , Heart Failure/etiology , Hemodynamics , Hirudin Therapy , Humans , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/mortality , Plasminogen Activators/therapeutic use , Prognosis , Prospective Studies , Recurrence , Reproducibility of Results , Risk , Thrombolytic Therapy , Ventricular Dysfunction, Left/etiology
9.
J Am Coll Cardiol ; 30(1): 133-40, 1997 Jul.
Article in English | MEDLINE | ID: mdl-9207634

ABSTRACT

OBJECTIVES: We sought to determine the prognostic value of the admission electrocardiogram (ECG) in patients with unstable angina and non-Q wave myocardial infarction (MI). BACKGROUND: Although the ECG is the most widely used test for evaluating patients with unstable angina and non-Q wave MI, little prospective information is available on its value in predicting outcome in the current era of aggressive medical and interventional therapy. METHODS: ECGs with the qualifying episode of pain were analyzed in patients enrolled in the Thrombolysis in Myocardial Ischemia (TIMI) III Registry, a prospective study of patients admitted to the hospital with unstable angina or non-Q wave MI. RESULTS: New ST segment deviation > or = 1 mm was present in 14.3% of 1,416 enrolled patients, isolated T wave inversion in 21.9% and left bundle branch block (LBBB) in 9.0%. By 1-year follow-up, death or MI occurred in 11% of patients with > or = 1 mm ST segment deviation compared with 6.8% of patients with new, isolated T wave inversion and 8.2% of those with no ECG changes (p < 0.001 when comparing ST with no ST segment deviation). Two other high risk groups were identified: those with only 0.5-mm ST segment deviation and those with LBBB, whose rates of death or MI by 1 year were 16.3% and 22.9%, respectively. On multivariate analysis, ST segment deviation of either > or = 1 mm or > or = 0.5 mm remained independent predictors of death or MI by 1 year. CONCLUSIONS: The admission ECG is very useful in risk stratifying patients with non-Q wave MI. The new criteria of not only > or = 1-mm ST segment deviation but also > or = 0.5-mm ST segment deviation or LBBB identify high risk patients, whereas T wave inversion does not add to the clinical history in predicting outcome.


Subject(s)
Angina, Unstable/physiopathology , Electrocardiography , Heart Conduction System , Myocardial Infarction/physiopathology , Myocardial Infarction/therapy , Thrombolytic Therapy , Aged , Angioplasty, Balloon, Coronary , Confounding Factors, Epidemiologic , Coronary Artery Bypass , Female , Humans , Male , Multivariate Analysis , Myocardial Infarction/drug therapy , Myocardial Infarction/surgery , Predictive Value of Tests , Proportional Hazards Models , Prospective Studies , Registries , Risk , Treatment Outcome
10.
Am J Cardiol ; 80(1): 21-6, 1997 Jul 01.
Article in English | MEDLINE | ID: mdl-9205014

ABSTRACT

Rescue percutaneous transluminal coronary angioplasty (PTCA) has been used to establish reperfusion after failed thrombolysis, and the goal of this study was to examine the angiographic and clinical outcomes after rescue PTCA performed for an occluded artery 90 minutes after thrombolysis. Four hundred two patients with acute myocardial infarction were randomized to receive either anistreplase (APSAC), recombinant tissue plasminogen activator, or their combination in the Thrombolysis in Myocardial Infarction (TIMI) 4 trial. The angiographic and clinical outcomes of patients with a patent artery 90 minutes after thrombolysis were compared with those of patients with an occluded artery treated in a nonrandomized fashion with either rescue or no rescue PTCA. At 90 minutes, the number of frames required to opacify standard landmarks (corrected TIMI frame count) was significantly lower (i.e., flow was faster) after successful rescue PTCA (27 +/- 11) than that in patent arteries after successful thrombolysis (39 +/- 20, p < 0.001), and the incidence of TIMI grade 3 flow was correspondingly higher after successful rescue PTCA (87% vs 65%, p = 0.002). In-hospital adverse outcomes (death, recurrent acute myocardial infarction, severe congestive heart failure, cardiogenic shock or an ejection fraction <40%) occurred in 29% of successful rescue PTCAs and in 83% of failed rescue PTCAs (p = 0.01). Among all patients in whom rescue PTCA was performed (successes and failures combined), 35% of patients experienced an adverse outcome, which was the same as the 35% incidence observed in patients not undergoing rescue PTCA (p = NS) and tended to be higher than the 23% incidence observed in patients with patent arteries (p = 0.07). Although successful rescue PTCA for an occluded artery at 90 minutes results in restoration of flow that is superior to that of successful thrombolysis, the incidence of adverse events for the strategy of rescue PTCA as a whole was the same as that of undertaking no PTCA.


Subject(s)
Angioplasty, Balloon, Coronary , Anistreplase/therapeutic use , Myocardial Infarction/therapy , Plasminogen Activators/therapeutic use , Tissue Plasminogen Activator/therapeutic use , Age Factors , Aged , Coronary Angiography , Double-Blind Method , Female , Humans , Male , Middle Aged , Multivariate Analysis , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/mortality , Recombinant Proteins , Recurrence , Survival Rate , Treatment Outcome , Vascular Patency
11.
JAMA ; 275(14): 1104-12, 1996 Apr 10.
Article in English | MEDLINE | ID: mdl-8601930

ABSTRACT

OBJECTIVE: To investigate the natural history and response to treatment of patients with unstable angina or non-Q-wave myocardial infarction (MI). DESIGN: Inception cohort. SETTING: Patients in general community, primary care, or referral hospitals. PATIENTS: All patients with an episode of unstable exertional chest pain or chest pain at rest presumed to be ischemic in origin lasting 5 minutes or more but without persisting ST-segment elevation greater than 30 minutes or the development of Q-waves were identified and enumerated in 18 participating hospitals. A subset of enumerated patients was selected to be followed prospectively using specific sampling strategies that would provide adequate numbers of black, women, and elderly (aged > or = 75 years) patients for comparison with their respective counterparts. MAIN OUTCOME MEASURES: The primary analysis compared the incidence of death or MI at 42 days after entry into the prospective study according to race, sex, and age. Other outcomes considered were recurrent ischemia and the combined outcomes of death, MI, or recurrent ischemia by 42 days after entry. RESULTS: A total of 8676 admissions with unstable angina or non-Q-wave MI were enumerated and, of these, 3318 patients were selected for the prospective study. The direct adjusted mean age of 3318 patients was 63.8 years. There were 943 blacks and 2375 nonblacks. Compared with nonblacks, blacks were less likely to be treated with intensive anti-ischemic therapy for their qualifying anginal episode and less likely to undergo invasive procedures (risk ratio [RR], 0.65%; 95% confidence interval [CI], 0.58 to 0.72; P<.001). However, of those who underwent angiography (45% of blacks and 61% of nonblacks), blacks had less extensive and severe coronary stenoses than nonblacks. The incidence of death and MI was similar for blacks and nonblacks, but blacks had a lower incidence of recurrent ischemia. There were 1678 men and 1640 women. Women were less likely than men to receive intensive anti-ischemic therapy and less likely to undergo coronary angiography (RR, 0.71; 95% CI, 0.65 to 0.78; P<.001). Women had less severe and extensive coronary disease and were less likely to undergo revascularization, yet had a similar risk of experiencing an adverse cardiac event by 6 weeks. There were 2490 patients aged 75 years or less and 828 patients aged more than 75 years. Elderly patients received less aggressive anti-ischemic therapy and were less likely to undergo coronary angiography than their younger counterparts. Elderly patients had more severe and extensive coronary disease but fewer revascularization procedures than younger patients and experienced a much higher incidence of adverse cardiac events both in hospital and by 6 weeks. CONCLUSIONS: Among patients presenting with acute ischemic chest pain without persistent ST-segment elevation, blacks appeared to have less severe coronary disease, received revascularization less frequently, and had less recurrent ischemia compared with nonblacks. Women were also found to have less severe coronary disease and were treated less intensely than men, but experienced similar outcomes. Elderly patients had more severe coronary disease than younger patients on coronary angiography, but were more likely to be treated medically, and they experienced far more adverse outcomes. These data suggest that more aggressive strategies should be directed to those patients with the greatest likelihood of adverse outcomes.


Subject(s)
Angina, Unstable/mortality , Angina, Unstable/therapy , Myocardial Infarction/mortality , Myocardial Infarction/therapy , Outcome and Process Assessment, Health Care , Age Factors , Aged , Angina, Unstable/physiopathology , Black People , Disease Progression , Electrocardiography , Female , Humans , Male , Middle Aged , Multivariate Analysis , Myocardial Infarction/physiopathology , Myocardial Ischemia/mortality , Myocardial Ischemia/physiopathology , Myocardial Ischemia/therapy , Prospective Studies , Recurrence , Sex Factors , Statistics as Topic , Survival Rate
13.
J Am Coll Cardiol ; 25(3): 582-9, 1995 Mar 01.
Article in English | MEDLINE | ID: mdl-7860900

ABSTRACT

OBJECTIVES: This study attempted to determine which lesion characteristics are associated with reocclusion by 18 to 36 h. BACKGROUND: Reocclusion of the infarct-related artery after successful reperfusion is associated with significant morbidity and up to a threefold increase in mortality. METHODS: Two hundred seventy-eight patients with acute myocardial infarction were randomized to receive either anisoylated plasminogen streptokinase activator complex (APSAC) or recombinant tissue-type plasminogen activator (rt-PA) or their combination. Culprit arteries were assessed for Thrombolysis in Myocardial Infarction (TIMI) flow grade, lesion ulceration, thrombus, collateral circulation and eccentricity. Minimal lumen diameter, percent diameter stenosis and lesion irregularity (power) were calculated using quantitative angiography. RESULTS: Reocclusion was observed more frequently in arteries with TIMI 2 versus TIMI 3 flow (10.4% vs. 2.2%, p = 0.003), in ulcerated lesions (10.7% vs. 3.0%, p = 0.009) and in the presence of collateral vessels (18.2% vs. 5.6%, p = 0.03). Similar trends were observed for eccentric (7.3% vs. 2.3%, p = 0.06) and thrombotic (8.4% vs. 3.3%, p = 0.06) lesions. Reocclusion was associated with more severe mean percent stenosis (77.9% vs. 73.9%, p = 0.04). Lesion length, reference segment diameter and Fourier measures of lesion irregularity were not associated with reocclusion. CONCLUSIONS: Several simply assessed angiographic variables, such as the presence of TIMI grade 2 flow, ulceration, collateral vessels and greater percent diameter stenosis at 90 min after thrombolytic therapy, are associated with significantly higher rates of infarct-related artery reocclusion by 18 to 36 h and may aid in identifying the subset of patients who are at significantly higher risk of early reocclusion and who potentially warrant further early pharmacologic or mechanical intervention.


Subject(s)
Anistreplase/therapeutic use , Cineangiography , Coronary Angiography , Myocardial Infarction/drug therapy , Thrombolytic Therapy , Tissue Plasminogen Activator/therapeutic use , Adult , Aged , Female , Humans , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Predictive Value of Tests , Recombinant Proteins/therapeutic use , Recurrence , Risk Factors
14.
J Am Coll Cardiol ; 24(7): 1602-10, 1994 Dec.
Article in English | MEDLINE | ID: mdl-7963104

ABSTRACT

OBJECTIVES: The aim of our study was to determine a superior thrombolytic regimen from three: anistreplase (APSAC), front-loaded recombinant tissue-type plasminogen activator (rt-PA) or combination thrombolytic therapy. BACKGROUND: Although thrombolytic therapy has been shown to reduce mortality and morbidity after acute myocardial infarction, it has not been clear whether more aggressive thrombolytic-antithrombotic regimens could improve the outcome achieved with standard regimens. METHODS: To address this issue, 382 patients with acute myocardial infarction were randomized to receive in a double-blind fashion (along with intravenous heparin and aspirin) APSAC, front-loaded rt-PA or a combination of both agents. The primary end point "unsatisfactory outcome" was a composite clinical end point assessed through hospital discharge. RESULTS: Patency of the infarct-related artery (Thrombolysis in Myocardial Infarction [TIMI] grade 2 or 3 flow) at 60 min after the start of thrombolysis was significantly higher in rt-PA-treated patients (77.8% vs. 59.5% for APSAC-treated patients and 59.3% for combination-treated patients [rt-PA vs. APSAC, p = 0.02; rt-PA vs. combination, p = 0.03]). At 90 min, the incidence of both infarct-related artery patency and TIMI grade 3 flow was significantly higher in rt-PA-treated patients (60.2% had TIMI grade 3 flow vs. 42.9% and 44.8% of APSAC- and combination-treated patients, respectively [rt-PA vs. APSAC, p < 0.01; rt-PA vs. combination, p = 0.02]). The incidence of unsatisfactory outcome was 41.3% for rt-PA compared with 49% for APSAC and 53.6% for the combination (rt-PA vs. APSAC, p = 0.19; rt-PA vs. combination, p = 0.06). The mortality rate at 6 weeks was lowest in the rt-PA-treated patients (2.2% vs. 8.8% for APSAC and 7.2% for combination thrombolytic therapy [rt-PA vs. APSAC, p = 0.02; rt-PA vs. combination, p = 0.06]). CONCLUSIONS: Front-loaded rt-PA achieved significantly higher rates of early reperfusion and was associated with trends toward better overall clinical benefit and survival than those achieved with a standard thrombolytic agent or combination thrombolytic therapy. These findings support the concept that more rapid reperfusion of the infarct-related artery is associated with improved clinical outcome.


Subject(s)
Anistreplase/therapeutic use , Myocardial Infarction/drug therapy , Thrombolytic Therapy , Tissue Plasminogen Activator/therapeutic use , Aged , Anistreplase/adverse effects , Aspirin/therapeutic use , Double-Blind Method , Drug Therapy, Combination , Female , Follow-Up Studies , Heparin/therapeutic use , Humans , Infusions, Intravenous , Male , Middle Aged , Myocardial Infarction/mortality , Vascular Patency
15.
Am J Cardiol ; 74(6): 531-7, 1994 Sep 15.
Article in English | MEDLINE | ID: mdl-8074033

ABSTRACT

Previous studies have reported that some patients presenting with unstable angina are found at coronary angiography to have no critical coronary stenosis. This study evaluated the clinical presentation and arteriographic findings in patients enrolled in the Thrombolysis in Myocardial Ischemia (TIMI-IIIA) trial, which assessed the effect of tissue-type plasminogen activator added to conventional therapy on the coronary arteriographic findings in patients presenting with ischemic pain at rest. Three hundred ninety-one patients were enrolled in the TIMI-IIIA trial and underwent coronary arteriography within 12 hours of enrollment. Fifty-three patients (14%) had no luminal diameter stenosis of a major coronary artery of > or = 60% on the baseline arteriogram. Compared with patients with unstable angina with an identifiable culprit lesion, patients without critical coronary obstruction were more likely to be women and non-white and less likely to have ST-segment deviation on the presenting electrocardiogram. Arteriography in such patients revealed no visually detectable coronary stenosis in half of the group; the remaining patients had noncritical coronary narrowing (i.e., < 60% luminal diameter stenosis) without morphologic features (ulceration or thrombus) suggestive of unstable or active coronary plaque. Nearly one third of the patients without critical coronary stenosis had impaired angiographic filling, suggesting a possible pathophysiologic role for coronary microvascular dysfunction. These patients with unstable angina and no critical coronary obstruction had an excellent short-term prognosis; 2% died or had myocardial infarction compared with 18% of patients with critical obstruction.


Subject(s)
Angina, Unstable/diagnosis , Angina, Unstable/diagnostic imaging , Angina, Unstable/ethnology , Angina, Unstable/physiopathology , Angina, Unstable/therapy , Coronary Angiography , Coronary Vessels/pathology , Electrocardiography , Female , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Predictive Value of Tests , Sex Factors , Treatment Outcome
16.
Cathet Cardiovasc Diagn ; 32(2): 99-107, 1994 Jun.
Article in English | MEDLINE | ID: mdl-8062380

ABSTRACT

The introduction of balloon valvuloplasty and new devices for coronary intervention has increased the incidence and changed the site and clinical presentation of cardiac perforation. We reviewed all cases of cardiac perforation that occurred during 11,845 consecutive catheterization procedures during a 6-yr period (1986-91). Fourteen cardiac perforations (overall incidence 0.12%) occurred as a result of the following procedures: mitral valvuloplasty 7 of 150 (4.7%), aortic valvuloplasty 4 of 260 (1.5%), pericardiocentesis 1 of 90 (1.1%), temporary pacer 1 of 1,660 (0.06%), and diagnostic left heart catheterization 1 of 6,965 (0.01%). Perforation was recognized in the catheterization laboratory in 11 patients, within 1 hr of leaving the laboratory in two patients, and 15 hr later in one patient. Hemodynamic evidence of tamponade developed in 13 patients and was confirmed by fluoroscopy (immobile heart borders) or echocardiography. Pericardiocentesis is definitive therapy in nearly half of the cases; the remaining patients require pericardiocentesis plus surgical repair of the perforation.


Subject(s)
Cardiac Catheterization/adverse effects , Cardiomyopathies/etiology , Cardiomyopathies/therapy , Aged , Aged, 80 and over , Cardiac Tamponade/etiology , Echocardiography , Female , Fluoroscopy , Humans , Male , Middle Aged , Prospective Studies
17.
Cathet Cardiovasc Diagn ; 31(3): 173-8, 1994 Mar.
Article in English | MEDLINE | ID: mdl-8025932

ABSTRACT

Restenosis rates following Palmaz-Schatz stenting vary between 13 and 36%. To determine whether the nearly three-fold interseries difference in restenosis rates reflects systematic factors (demographic and procedural variables such as post-treatment lumen diameter) rather than random variation, we pooled 486 lesions treated with the Palmaz-Schatz coronary stent in the U.S. Multicenter Registry (n = 259) with the single-center Beth Israel Hospital experience (n = 227) and analyzed the combined series using a continuous geometric model of restenosis. A greater proportion of lesions (66 vs. 50%; P < 0.001) in the Multicenter cohort represented restenosis after a prior intervention. The Multicenter experience also showed a smaller minimum lumen diameter following stent placement (2.61 vs. 3.43 mm; P < 0.001), higher post-stent percent stenosis (16 vs. -2%; P < 0.001), and less acute gain (1.79 vs. 2.67 mm; P < 0.001) than lesions treated in the Beth Israel cohort. At 6-month follow-up, the angiographic restenosis rate (> or = 50% diameter stenosis) was significantly higher in the Multicenter group (35 vs. 27%; P = 0.05), despite the development of less absolute late loss (0.96 vs. 1.32 mm; P < 0.001). Multivariable modeling, however, showed that the only independent predictors of restenosis were a post-procedure lumen diameter < 2.80 mm (odds ratio = 1.57; P = 0.04), diabetes mellitus (odds ratio = 3.55; P < 0.001), and prior restenosis (odds ratio = 1.84; P = 0.008).(ABSTRACT TRUNCATED AT 250 WORDS)


Subject(s)
Coronary Disease/therapy , Stents , Cohort Studies , Coronary Angiography , Coronary Disease/epidemiology , Coronary Vessels/pathology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Multivariate Analysis , Recurrence , Registries , Retrospective Studies , Time Factors
18.
Am J Cardiol ; 72(13): 71E-79E, 1993 Oct 18.
Article in English | MEDLINE | ID: mdl-8213574

ABSTRACT

This study investigates whether adjunctive balloon angioplasty can be safely used to improve acute results in cases where directional coronary atherectomy alone has provided a successful (but suboptimal) outcome. Between October 1, 1990, and October 1, 1992, directional coronary atherectomy was performed successfully in 198 of 228 lesions. Individual operators believed that most acute results were satisfactory after atherectomy alone (group I, n = 115) with a minimal lumen diameter that increased from 0.82 +/- 0.45 to 3.21 +/- 0.65 mm after atherectomy, for an acute gain in lumen diameter of 2.39 +/- 0.73 mm and a residual stenosis of 6 +/- 13%. In 42% of lesions (group II, n = 83), however, results were considered suboptimal after atherectomy alone, with a minimal lumen diameter that increased from 0.85 +/- 0.45 to 2.83 +/- 0.64 mm, a smaller acute gain of 1.96 +/- 0.72 mm, and a mean residual stenosis of 17 +/- 14% (although all residual stenoses were < 50%, 19% had a residual stenosis > 30%). Adjunctive balloon angioplasty in these group II lesions provided an additional gain of 0.34 +/- 0.38 mm, bringing the total acute gain for group II lesions to 2.32 +/- 0.78 mm and the residual stenosis to 9 +/- 13%, similar to that of group I patients who underwent atherectomy alone. This strategy resulted in a 7 +/- 13% overall residual stenosis for the study population, with no higher incidence of periprocedural complications or adverse late clinical outcomes in group II patients.(ABSTRACT TRUNCATED AT 250 WORDS)


Subject(s)
Angioplasty, Balloon, Coronary , Atherectomy, Coronary , Coronary Artery Disease/therapy , Combined Modality Therapy , Coronary Angiography , Coronary Artery Disease/epidemiology , Coronary Artery Disease/surgery , Coronary Vessels/pathology , Female , Follow-Up Studies , Humans , Incidence , Male , Middle Aged , Postoperative Complications/epidemiology , Prevalence , Retrospective Studies , Time Factors , Treatment Outcome
19.
N Engl J Med ; 327(19): 1329-35, 1992 Nov 05.
Article in English | MEDLINE | ID: mdl-1406834

ABSTRACT

BACKGROUND: Percutaneous balloon mitral valvuloplasty is known to produce short-term hemodynamic and symptomatic improvement in many patients with mitral stenosis. Comprehensive assessment of the clinical usefulness of balloon valvuloplasty requires evaluation of patients' long-term outcomes. METHODS: We performed balloon mitral valvuloplasty in 146 patients between October 1, 1985, and October 1, 1991. Base-line demographic, clinical, echocardiographic, and hemodynamic variables were evaluated in order to identify predictors of long-term event-free survival. RESULTS: Balloon mitral valvuloplasty was completed successfully in 136 (93 percent) of the patients in whom the procedure was attempted; it resulted in an increase in the mean (+/- SD) mitral-valve area from 1.0 +/- 0.4 to 2.1 +/- 0.9 cm2 and a decrease in the mean transmitral pressure gradient from 14 +/- 5 to 6 +/- 3 mm Hg (P < 0.001 for both comparisons). The estimated overall five-year survival rate was 76 +/- 5 percent, and the estimated five-year event-free survival rate (the percentage of patients without mitral-valve replacement, repeat valvuloplasty, or death from cardiac causes) was 51 +/- 6 percent. According to multivariate Cox proportional-hazards analysis, the independent predictors of longer event-free survival were a lower mitral-valve echocardiographic score (a measure of mitral-valve deformity; range, 0 for a normal valve to 16 for a seriously deformed valve; P < 0.001), lower left ventricular end-diastolic pressure (P = 0.001), and a lower New York Heart Association (NYHA) functional class (P = 0.04). Patients with no risk factors for early restenosis or only one risk factor (echocardiographic score > 8, left ventricular end-diastolic pressure > 10 mm Hg, or NYHA functional class IV) had a predicted five-year event-free survival rate of 60 to 84 percent, whereas patients with two or three risk factors had a predicted five-year event-free survival rate of only 13 to 41 percent. CONCLUSIONS: Balloon mitral valvuloplasty as a treatment for selected patients with mitral stenosis has good long-term results. The long-term outcome after this procedure can be predicted on the basis of patients' base-line characteristics.


Subject(s)
Catheterization , Mitral Valve Stenosis/therapy , Echocardiography , Female , Follow-Up Studies , Humans , Male , Middle Aged , Mitral Valve Stenosis/mortality , Mitral Valve Stenosis/physiopathology , Prognosis , Proportional Hazards Models , Survival Rate
20.
J Am Coll Cardiol ; 20(5): 1101-10, 1992 Nov 01.
Article in English | MEDLINE | ID: mdl-1401610

ABSTRACT

OBJECTIVES: This study was performed to obtain better understanding of the long-term clinical efficacy of directional coronary atherectomy. BACKGROUND: Although this procedure yields favorable acute results, its acceptance has been limited by the perception that late results (that is, freedom from restenosis) are no better than those of conventional angioplasty. METHODS: A total of 225 atherectomies performed in 190 patients between August 1988 and July 1991 were examined. Minimal lumen diameter of the treated segments was measured on angiograms obtained before, after and 6 months after intervention. RESULTS: Although most lesions (97%) had one or more characteristics predictive of unfavorable short- or long-term results after conventional angioplasty, atherectomy was successful in 205 lesions (91%) with a mean residual stenosis of 7 +/- 16%. After subsequent balloon angioplasty in 16 unsuccessful atherectomy attempts, procedural success was 98%. There were no deaths or Q wave myocardial infarctions, and one patient (0.5%) underwent emergency bypass surgery. Six-month angiographic follow-up was obtained in 77% of the eligible patients. The overall angiographic restenosis rate was 32%. Predictors of a lower restenosis rate included a postprocedure lumen diameter > 3 mm (24% vs. 39%, p = 0.047), serum cholesterol < or = 200 mg/dl (18% vs. 40%, p = 0.018) and recent myocardial infarction (16% vs. 37%, p = 0.034). Life-table analysis showed a 2% mortality rate and a 26% incidence of other events (myocardial infarction, repeat revascularization) within the 1st year. The annual 5% mortality rate and 7% incidence of other events during years 2 and 3 were related in large part to the existence or progression of disease at other locations. CONCLUSIONS: Six-month angiographic follow-up of patients who underwent directional coronary atherectomy during the 1st 3 years of our experience shows an overall restenosis rate of 32%, with lower rates in patients with a postatherectomy lumen diameter > or = 3 mm, cholesterol level < or = 200 mg/dl or a recent myocardial infarction. Few if any events relating to the site of atherectomy developed after the 1st year of follow-up.


Subject(s)
Atherectomy, Coronary , Atherectomy, Coronary/instrumentation , Atherectomy, Coronary/methods , Atherectomy, Coronary/statistics & numerical data , Boston/epidemiology , Chi-Square Distribution , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/epidemiology , Coronary Artery Disease/surgery , Coronary Vessels/pathology , Follow-Up Studies , Humans , Postoperative Complications/epidemiology , Prognosis , Recurrence , Regression Analysis , Time Factors
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